The Clinical Course and Factors for the Progression of Uninvestigated Dyspepsia to Functional Dyspepsia

Dyspepsia Clinical Trial

Official title:

The Clinical Course and Factors for the Progression of Uninvestigated Dyspepsia to Functional Dyspepsia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05823636
• Other study ID #: KY20222180-F-5
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: December 31, 2023

Study information

• Verified date: April 2023
• Source: Air Force Military Medical University, China
• Contact: Yanglin Pan, MD
• Phone: 13991811225
• Email: yanglinpan[@]hotmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Dyspepsia is one of the most common gastrointestinal diseases. This disease was defined as predominant epigastric pain lasting for at least 1 month, which can be accompanied with other symptoms, such as epigastric fullness, and early satiety. Despite dyspepsia symptoms lasting for ≥1 month represented clinical problem, a longer duration of 6 months or more after first-onset symptom was required for the diagnosis of functional dyspepsia based on ROME IV criteria. It was unclear about the natural procession of first-onset dyspepsia to functional dyspepsia assessed by Rome IV or Asia criteria and possible factors associated with this progression.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 220
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients aged = 18 years old who had first-onset dyspepsia with one or more symptoms of epigastric pain, epigastric burning, postprandial fullness, early satiation and that has lasted for more than 1 month to 3 months.

Exclusion Criteria:

1. Patients with local or systemic diseases which may cause dyspeptic symptoms:

Known active peptic ulcer, cholecystitis, gallstone, gastrointestinal obstruction, gastroparesis, and etc.

2. Known acute or chronic injury of liver or kidney

3. Obvious hematological abnormality, or endocrine and metabolic diseases

4. Known malignancy; Obvious cardiovascular or cerebrovascular diseases (such as coronary heart disease, arrhythmia, cerebral infarction and etc.

5. Other conditions which may be associated with dyspeptic symptoms (such as NSAIDs associated dyspepsia)

6. organ failure defined by Marshall standard or severe psychiatric illnesses

7. pregnancy or lactation

8. unable to provide consent

Related Conditions & MeSH terms

• Dyspepsia

Locations

Country	Name	City	State
China	Air Force Military Medical University, China	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Air Force Military Medical University, China

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional dyspepsia defined by ROME IV criteria	Met the following criteria: by one or more of the following symptoms: postprandial fullness, early satiation, epigastric pain, and epigastric burning that are unexplained after a routine clinical evaluation, Criteria fulfilled for the last 3 months with symptom onset at least 6 months before diagnosis.	6 months
Secondary	Functional dyspepsia defined by Asia criteria:	Met the following criteria: by one or more of the following symptoms: postprandial fullness, early satiation, epigastric pain, and epigastric burning that are unexplained after a routine clinical evaluation, the symptoms duration?3 months.	3 month
Secondary	Global Overall Symptom score (GOSS)	The GOSS consists of 10 cardinal items (epigastric pain, epigastric discomfort, Heartburn, acid regurgitation, upper abdominal bloating, belching, nausea, early satiety, postprandial fullness, other epigastric symptoms(eg. epigastric burning). Each item can be scored from 1 (no) to 7 (worst).	1month, 3 months, 6 months
Secondary	Number of participants subclassified into different subtypes of functional dyspepsia defined by ROME IV criteria	Functional dyspepsia was classified into three subgroups:(1) Postprandial Distress Syndrome, defined as Bothersome postprandial fullness or/and Bothersome early satiation. (2) Bothersome epigastric pain AND/OR Bothersome epigastric burning. (3) mixed syndrome, defined when postprandial distress syndrome and epigastric pain syndrome presented simultaneously.	6 months
Secondary	Short Form of Nepean Dyspepsia Index (SF-NDI)	The SF-NDI consists of 10 questions regarding the effects of dyspepsia symptoms ("stomach problems") on different aspects of life (tension, interference with daily activities, eating/drinking, knowledge/control, and work/study). Each response can be from 1 (not at all affected) to 5 (extremely affected), or 0 (N/A), for a total summed score out of 50.	1month, 3 months, 6 months
Secondary	Hospital anxiety and depression scale	Anxiety and depression of patients are assessed by using Hospital Anxiety and Depression Scale.It contains 14 items (7 anxiety and 7 depression), which assess symptoms experienced during the past week on a 0-3 scale. A subscore of > 8 for depression or anxiety would indicate a clinical case.	1month, 3 months, 6 months
Secondary	Quality of Life scores	Quality of Life scores assessed by Patient-reported outcomes measurement information system (PROMIS) Global-10 questionnaire. PROMIS Global-10 is a newly validated 10-question survey used to assess health care-related quality of life measures for the general population.; It's a 10-item patient-reported questionnaire in which the response options are presented as 5-point (as well as a single 11-point) rating scales. These scores are then standardized to the general population, using the "T-Score". The average "T-Score" for the United States population is 50 points, with a standard deviation of 10 points. Higher scores indicate a healthier patient and a better quality of life.	1month, 3 months, 6 months
Secondary	Self-reported severity of symptoms by patients	Patients rated the severity of dyspepsia as mild, moderate, and severe by themselves	1 day
Secondary	Number of participants with other functional gastrointestinal diseases defined by ROME IV criteria	Recurrent functional dysphagia, reflux hypersensitivity, irritable bowel syndrome, etc.	1 day